Social Anxiety Disorder, Social Phobia
Conditions
Keywords
Social Anxiety, Information Processing, Interpretation
Brief summary
Generalized Social Phobia is characterized by severe social anxiety that leads to functional impairment (Schneider et al., 1992). Despite its high prevalence, many individuals do not receive treatment or are unresponsive to current therapies. Thus there is a clear need to continue to develop highly effective and efficient treatments for social phobia. This three year project aims to test a computerized treatment for social phobia in a double-blind, placebo-controlled study designed to modify interpretation biases that may maintain anxiety.
Detailed description
Social phobia is characterized by severe social anxiety leading to functional impairment (Schneider et al., 1992). Despite its high prevalence (13%, Kessler et al., 1994) over 30% of individuals with social anxiety who need treatment do not receive treatment (Olfson, et al., 2000) and 40% of individuals who present for treatment do not respond (39%, Heimberg, et al., 1998; 42%, Liebowitz et al., 2005). Thus, there is a clear need to develop highly effective and efficient treatments for GSP. Reducing negative interpretation of social events is an efficacious treatment for SP because: 1. benign interpretations is associated with improvement in social anxiety after treatment (e.g., Franklin, Huppert, Langner, Leiberg, & Foa, 2005) 2. negative interpretations are implicated in the pathogenesis of SP (e.g., Rapee & Heimberg, 1997) 3. SPs have more negative interpretations of social events than non-anxious controls and individuals with other anxiety disorders (e.g., Amir et al, 1998) 4. this bias ameliorates after successful treatment (e.g., Stopa & Clark, 2000). Therefore, changing negative interpretations is an efficacious treatment for SP, and current cognitive-behavioral therapies use cognitive restructuring (CR) to target negative interpretations and replace them with more benign interpretations (Heimberg, et al., 1998). The goal of the current proposal is to test a new computerized treatment for SP that is designed to change negative interpretations. We chose a computerized intervention to increase efficiency and ease of delivery. We chose to test this intervention in GSP because interpretation bias is especially relevant to this clinical population. The long-term goal of this project is to improve service delivery using a widely available and economical intervention for GSP. More specifically, we will test three hypotheses in this proposal: 1. Individuals with GSP completing the Interpretation Modification Program (IMP) will show a reduction in their negative interpretation 2. Participants in the IMP will show a decrease in their social anxiety symptoms 3. Change in social anxiety symptoms will be mediated by the change in interpretation scores, suggesting that interpretation change reduced social anxiety symptoms. Pilot data (n=34) suggest that this intervention is efficacious. Thus, we aim to develop further and validate this highly efficient treatment for changing interpretations as a cost-effective treatment for patients with social phobia.
Interventions
BEHAVIORALInterpretation Modification Program
The IMP protocol includes twelve 30-min sessions delivered over a 6-week period. Each session will comprise 220 trials. In each trial, participants will first see either a non-threat or a threat (e.g. graceful or clumsy) word on the computer screen. They will then see an ambiguous sentence (e.g. You dance at the party) and will be asked to indicate if the word and sentence were related by pressing a corresponding key. Participants will receive positive feedback (i.e., You are correct!) when they endorse a non-threat interpretation or reject a threat interpretation of an ambiguous sentence. Participants will receive negative feedback (i.e., You are incorrect.) when they endorse a threat interpretation or reject a non-threat interpretation of an ambiguous sentence.
BEHAVIORALInterpretation Control Condition
Participants assigned to the PC completed an identical procedure to the IMP procedure except that feedback about participants' performance was not contingent on the type of interpretation (i.e., non-threat or threat) endorsed. Thus, participants in the PC received positive feedback 50% of the time when viewing a threat interpretation and 50% of the time when viewing a non-threat interpretation.
Sponsors
National Institute of Mental Health (NIMH)
San Diego State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Principle DSM-IV-TR (APA, 2000) Diagnosis of social phobia - Generalized Type (GSP)
Exclusion criteria
* No change in medication type or dosage twelve weeks prior to initiating treatment * No current psychotherapy * No evidence of suicidal intent * No evidence of substance abuse in the last 6 months * No evidence of current or past schizophrenia, bipolar disorder, or organic mental disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liebowitz Social Anxiety Scale (LSAS) | Pre, Post (6 weeks), Followup (3 months after post-assessment) | Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Phobia and Agoraphobia Inventory | Pre, Post (6 weeks), Followup (3 months after post-assessment) | Our secondary outcome assessment of social anxiety symptoms was the Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, & Stanley, 1989), a 45-item self-rated measure that assesses the cognitive, behavioral, and somatic dimensions of SAD. SPAI scores range from 45 to 315, with higher scores indicating more severe symptoms. Previous research suggests that the SPAI has sound psychometric properties (e.g., Turner et al., 1989). Internal consistencies for these measures in the current sample were satisfactory. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interpretation Modification Program The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min. | 23 |
| Interpretation Control Condition The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction. | 26 |
| Total | 49 |
Baseline characteristics
| Characteristic | Interpretation Modification Program | Interpretation Control Condition | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 26 Participants | 49 Participants |
| Region of Enrollment United States | 23 participants | 26 participants | 49 participants |
| Sex: Female, Male Female | 19 Participants | 16 Participants | 35 Participants |
| Sex: Female, Male Male | 4 Participants | 10 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 26 |
| serious Total, serious adverse events | 0 / 23 | 0 / 26 |
Outcome results
Primary
Liebowitz Social Anxiety Scale (LSAS)
Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms.
Time frame: Pre, Post (6 weeks), Followup (3 months after post-assessment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interpretation Modification Program | Liebowitz Social Anxiety Scale (LSAS) | pre-tx | 82.0 units on a scale | Standard Deviation 18.4 |
| Interpretation Modification Program | Liebowitz Social Anxiety Scale (LSAS) | post | 50.2 units on a scale | Standard Deviation 19.3 |
| Interpretation Modification Program | Liebowitz Social Anxiety Scale (LSAS) | follow-up | 40.8 units on a scale | Standard Deviation 21.6 |
| Interpretation Control Condition | Liebowitz Social Anxiety Scale (LSAS) | pre-tx | 77.7 units on a scale | Standard Deviation 18.6 |
| Interpretation Control Condition | Liebowitz Social Anxiety Scale (LSAS) | post | 67.6 units on a scale | Standard Deviation 26.2 |
| Interpretation Control Condition | Liebowitz Social Anxiety Scale (LSAS) | follow-up | NA units on a scale | — |
Secondary
Social Phobia and Agoraphobia Inventory
Our secondary outcome assessment of social anxiety symptoms was the Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, & Stanley, 1989), a 45-item self-rated measure that assesses the cognitive, behavioral, and somatic dimensions of SAD. SPAI scores range from 45 to 315, with higher scores indicating more severe symptoms. Previous research suggests that the SPAI has sound psychometric properties (e.g., Turner et al., 1989). Internal consistencies for these measures in the current sample were satisfactory.
Time frame: Pre, Post (6 weeks), Followup (3 months after post-assessment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interpretation Modification Program | Social Phobia and Agoraphobia Inventory | pre-tx | 145.0 units on a scale | Standard Deviation 26.8 |
| Interpretation Modification Program | Social Phobia and Agoraphobia Inventory | post-tx | 112.0 units on a scale | Standard Deviation 34.4 |
| Interpretation Modification Program | Social Phobia and Agoraphobia Inventory | follow-up | 94.7 units on a scale | Standard Deviation 37.7 |
| Interpretation Control Condition | Social Phobia and Agoraphobia Inventory | pre-tx | 146.1 units on a scale | Standard Deviation 21.8 |
| Interpretation Control Condition | Social Phobia and Agoraphobia Inventory | post-tx | 118.1 units on a scale | Standard Deviation 43.7 |
| Interpretation Control Condition | Social Phobia and Agoraphobia Inventory | follow-up | NA units on a scale | — |